Difficult IntubationNCT02476565
Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
A study testing LMA-Supreme supraglottic device and I-gel supraglottic device in people with Difficult Intubation, run by Vanderbilt University at 2 sites in United States.
Trial summary
The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- LMA-Supreme supraglottic device and I-gel supraglottic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery.
- Age >18 years old.
- Can provide informed consent.
Who cannot join
- Subjects that require rapid sequence induction for endotracheal intubation; i.e., parturients, or any subject that is at high risk for aspirating gastric contents into the airway.
- Subjects that have an allergy to Propofol or eggs.
- Subjects that have an allergy to rocuronium.
- Subjects with a history of oropharyngeal or laryngeal surgery, or subjects undergoing oropharyngeal or laryngeal surgery.
- Subjects with congenital or anatomical airway anomalies.
- Subjects with anticipated reduced functional residual capacity as predicted by a body mass index ≥40.
- Currently enrolled in another research study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
South Texas Veterans HealthCare System
San Antonio, Texas, 78229
About this study
The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices
Read the detailed description
With the proposal, the investigators are comparing two different types of supraglottic devices. One is the LMA Supreme (laryngeal mask airway) and the other is the I-gel. The study is designed to use the supraglottic airway device as an adjunct to tracheal intubation, not as the definitive airway. The investigators will be utilizing the Aintree intubation catheter over the fiberoptic bronchoscope in an effort to secure the airway. This technique has been well described in the literature and has been proven effective and safe.
- Conditions
- Difficult Intubation
- Being tested
- LMA-Supreme supraglottic device, I-gel supraglottic device
- Keywords
- Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA-Supreme supraglottic deviceDevice
The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
I-gel supraglottic deviceDevice
The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
| Study group | Role | What they receive |
|---|---|---|
| LMA-Supreme supraglottic device | Experimental | The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff Receives: Device: LMA-Supreme supraglottic device |
| I-gel supraglottic device | Active comparator | The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. Receives: Device: I-gel supraglottic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Tracheal Intubation
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
Measured: Up to 10 minutes
Secondary outcomes (6)
Time to Placement of the Supra Glottic Device
This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide
Measured: Up to 10 minutes
Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device
Measured: Up to 10 minutes
Time to Placement of the Aintree Airway Intubation Catheter
This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down
Measured: Up to 10 minutes
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.
Measured: Up to 10 minutes
Time to Placement of the Endotrotracheal Tube
Time to the appropriate placement of the endotracheal tube.
Measured: Up to 10 minutes
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube
Measured: Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Hernandez, Vanderbilt University
- Investigators
- Antonio Hernandez, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476565
- Sponsor's protocol ID
- 131507
- Status last verified
- Feb 2018
- First submitted
- 3 Jun 2015
- Last updated
- 16 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
- ClinicalTrials.gov ID
- NCT02476565
- Acronym / sponsor ID
- 131507
- Conditions
- Difficult Intubation
- Keywords
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 18 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices
Detailed description
With the proposal, the investigators are comparing two different types of supraglottic devices. One is the LMA Supreme (laryngeal mask airway) and the other is the I-gel. The study is designed to use the supraglottic airway device as an adjunct to tracheal intubation, not as the definitive airway. The investigators will be utilizing the Aintree intubation catheter over the fiberoptic bronchoscope in an effort to secure the airway. This technique has been well described in the literature and has been proven effective and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA-Supreme supraglottic device | Experimental | Device: LMA-Supreme supraglottic deviceThe LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff |
| I-gel supraglottic device | Active comparator | Device: I-gel supraglottic deviceThe I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery.
- Age >18 years old.
- Can provide informed consent.
Key exclusion criteria (7 listed)
- Subjects that require rapid sequence induction for endotracheal intubation; i.e., parturients, or any subject that is at high risk for aspirating gastric contents into the airway.
- Subjects that have an allergy to Propofol or eggs.
- Subjects that have an allergy to rocuronium.
- Subjects with a history of oropharyngeal or laryngeal surgery, or subjects undergoing oropharyngeal or laryngeal surgery.
- Subjects with congenital or anatomical airway anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA-Supreme supraglottic deviceThe fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. | Device | LMA-Supreme supraglottic device |
| I-gel supraglottic deviceThe fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. | Device | I-gel supraglottic device |
Primary outcome
Time to Successful Tracheal Intubation
Time frame: Up to 10 minutes
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
6 secondary outcomes
Time to Placement of the Supra Glottic Device
Time frame: Up to 10 minutes
Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
Time frame: Up to 10 minutes
Time to Placement of the Aintree Airway Intubation Catheter
Time frame: Up to 10 minutes
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
Time frame: Up to 10 minutes
Time to Placement of the Endotrotracheal Tube
Time frame: Up to 10 minutes
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
Time frame: Up to 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Hernandez, MD principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA-Supreme supraglottic device and I-gel supraglottic device in people with Difficult Intubation, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Tracheal Intubation (time frame: Up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.